FDA win: Cancer drug granted market exclusivity for blood cancer

The US Food and Drug Administration has granted ‘orphan drug designation’ to PTX-100 for the treatment of peripheral T-cell lymphomas, paving the way for Prescient Therapeutics to lock in years of market exclusivity.

The US Food and Drug Administration has granted ‘orphan drug designation’ to PTX-100 for the treatment of peripheral T-cell lymphomas, paving the way for Prescient Therapeutics to lock in years of market exclusivity.

Prescient (ASX: PTX), an Australian biotech company that develops personalised therapies to treat cancer, said the designation from the Office of Orphan Products Development represents a “significant” step forward for its targeted therapy.

Orphan status is granted to drugs defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases that affect fewer than 200,000 people in the US – and is designed to provide benefits to incentivise drug development in less common diseases.

“Orphan drugs often enjoy shorter and cheaper development pathways,” Prescient CEO and managing director Steven Yatomi-Clarke said.

“Additionally, the company now has the certainty of seven years of market exclusivity in the event of regulatory approval of PTX-100 for PTCL (peripheral T-cell lymphomas).”

Peripheral T-cell lymphomas are a blood cancer with high unmet clinical need, Mr Yatomi-Clarke said, adding that survival following relapse is poor and has not significantly improved in the past 20 years.

PTX-100, however, has shown an encouraging efficacy signal in peripheral T-cell lymphomas in the dose escalation of a Phase 1b basket study, and is now in an expansion cohort of patients under the leadership of globally renowned lymphoma expert Professor H. Miles Prince.

The expansion cohort is due to fully recruit this year.

Further to its designation success, Prescient – which sits at the forefront of the current revolution within oncology, the largest sector in healthcare at US$280 billion – was recently granted a key US patent for its OmniCAR platform.

The patent ensures protection for its flagship platform in the US, the world’s largest healthcare market, until at least 2039.

Prescient Therapeutics CEO Steven Yatomi-Clarke will join Horizon 3 Biotech CIO Matt McNamara and Reach Markets MD Patrick Nelson for our The Insider: Biotech Special Event tomorrow, Thursday 21st July at 12.30pm (AEST), where the panellists will discuss how to uncover opportunities within the sector. Click here to book yourself in.

Reach Markets have been engaged by PTX to assist with their investor communications.

Sources:

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